Controlled strain skin treatment devices and methods

ABSTRACT

Devices, kits and methods described herein may be for wound healing, including but not limited to the treatment, amelioration, or prevention of scars and/or keloids. The packaging, manipulation elements, applicator and/or tensioning device maybe used to apply and/or maintain a strain in an elastic dressing.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.13/411,394, filed Mar. 2, 2012, which claims benefit under 35 U.S.C.§119(e) to a) U.S. Provisional Application Ser. No. 61/448,809, filed onMar. 3, 2011, b) U.S. Provisional Application Ser. No. 61/476,163, filedon Apr. 15, 2011, and c) U.S. Provisional Application Ser. No.61/605,717, filed on Mar. 1, 2012, all of which are hereby incorporatedby reference in their entirety. This application is also related to U.S.application Ser. No. 11/888,978, filed on Aug. 3, 2007, and U.S.application Ser. No. 12/854,859, filed on Aug. 11, 2010, all of whichare hereby incorporated by reference in their entirety.

BRIEF SUMMARY

Devices, kits and methods described herein may be for treatment of asubject at a skin site including without limitation for wound treatmentor the treatment, amelioration, or prevention of scars and/or keloids,by manipulating mechanical or physical properties of skin or byshielding skin from stresses, and/or by controllably stressing orstraining the epidermis and layers of dermal tissue at or near a skinsite, i.e., at or adjacent a wound or a treatment site of a subject'sskin. According to variations, manipulating mechanical or physicalproperties may thereby modulate tensile or compressive stress at theskin site. The stress at the skin site may be reduced to levels belowthat experienced by normal skin and tissue. The stress at the skin sitemay be increased to levels above that experienced by normal skin andtissue. The stress or strain may be applied to surrounding tissue inone, two, or more directions to manipulate endogenous or exogenousstress at the skin site in one, two or more directions. According tovariations, devices and methods described herein may reduce or otherwisemanipulate the stress experienced by skin and/or a wound and surroundingtissues in order to treat a subject. The devices may also assist inpreventing or reducing the incidence of wound dehiscence.

According to the devices, kits and methods described herein, a skintreatment device, skin device, wound treatment device, scar or keloidtreatment device, scar or keloid amelioration or prevention device,bandage, or dressing may be provided that may be applied, attached to orcoupled to one or more layers of the skin or tissue of a subject(hereinafter referred to as “dressing”, “skin device” or “skin treatmentdevice”).

In addition to amelioration of scar formation, other uses for such skintreatment device may or may not include without limitation, for example,treating skin related conditions such as acne, blemishes, rosacea,warts, rashes (including but not limited to erythematous, macular,papular and/or bullous conditions), psoriasis, skinirritation/sensitivity, allodynia, telangiectasia, port wine stains andother arterio-venous malformations, and ectopic dermatitis; treating orimproving existing scars, wrinkles, stretch marks, loose or sagging skinor other skin irregularities; lifting, pinning, holding, moving skin forvarious purposes such as during pre-operative preparation, duringsurgical procedures for example as a low-profile tissue retractor, tostabilize blood vessels during needle or catheter insertion,postoperatively, pre or post operatively for pre-treating orpreconditioning skin for example, prior to scar revision, woundincision, body contouring, in mastectomy skin expansion, aesthetic skintreatment or resurfacing whether topical or subdermal, whether or notusing an energy modality such as, for example, microwave,radio-frequency ablation, high-intensity focused ultrasound, laser,infrared, incoherent light, thermal (heat and/or cold, ablative ornon-ablative), use of vacuum or suction, vibration or massage (e.g.ENDERMOLOGIE®, LPG Systems, France), during weight loss, or foraesthetic purposes; hair removal or hair loss; treating and/or closingskin injuries for example, incisions, wounds, chronic wounds, bed sores,ulcers (including venous stasis ulcers), preventing or reducing theincidence of wound dehiscence, diabetic skin or wound conditions, burnhealing and/or relief; acting as an occlusive or negative-pressure wounddressing; protecting incisions or wounds, e.g. prevention of splittingor opening, protecting newborn belly buttons after cutting umbilicalcord. Such treatments may include use of a drug or other therapeuticagent that may be applied to the skin with such device. The agents mayinclude but are not limited to antibiotics, anti-fungals, immunemodulators including corticosteroids and non-steroidal immunemodulators. The agents may be provided in any of a variety offormulations, including but not limited powders, gels, lotions, creams,pastes, suspensions, etc. The devices may also be used for purposes ofdelivering a drug to the skin or through the skin, for example bystretching the skin and applying a drug thereto. Differentconfigurations of the device may be amenable to the size or geometry ofdifferent body regions. The treatments may be applied to regions of anyshape (e.g. linear, curved, stellate), size or depth, and to one or moreregions of the body, including but not limited to the scalp, forehead,face (e.g. nose, eyelid, cheeks, lips, chin), ears, neck, shoulder,upper arm, lower arm, palm, dorsum of the hand, fingers, nailbed,axilla, chest, nipple, areola, back, abdomen, inguinal region, buttocks,perineal region, labia, penis, scrotum, thigh, lower leg, plantarsurface of the foot, dorsal surface of the foot, and/or toes. Suchdevices may also be referred to herein as a “dressing”, “skin device” or“skin treatment device”.

The devices, kits or methods described herein may include a packaging,carrier, support, base, applicator, handles, manipulation elements e.g.for mechanical application of force, and/or tensioning device, each ofwhich may: contain, hold, carry or support a dressing at leasttemporarily; may be used to prepare a dressing for application; may beused to exert a tensioning, straining and/or stretching force to adressing, e.g., prior to application to a subject; may be used todeliver, orient or apply a dressing; may be used to maintain a dressingin a stressed or strained configuration; may be used to stress or straina dressing; may be used to separate the dressing from the packaging,carrier, support, base, applicator or tensioning device and/or may beused during or after application of a dressing to provide additionaltreatment to a wound, incision or other treatment location; and/or maybe used to apply pressure to a wound, incision or other treatmentlocation. According to some variations, a packaging, manipulationelements, backing support and/or applicator may provide structuralsupport for a dressing while or after an adhesive liner is released.According to some variations, an assembly may be constructed to avoidfolding or bending of the dressing to the extent that the adhesive onthe dressing sticks to itself. For example, when some variations of thedressing are held or supported at one point or along one edge of thedressing in a cantilever configuration, the dressings will not bow,laterally deform, or otherwise deform out of plane, under their own massor configuration.

In some other variations of the devices and methods herein, a devicewith a substantially rigid support structure or that provides structuralsupport to a dressing and that provides a particular resistance tobending or column strength when two opposing edges of the device andsupport structure are placed under a compressive load that causes axialcompression or lateral deformation, e.g. a force similar to a handgrasping force is applied to an edge of the device, before the devicebuckles or folds. For example, a resistance to bending may becharacterized as the peak force that is achieve as the device andsupport structure are compressed without compressed by 25% of itsoriginal dimension. This column strength or rigidity may vary, dependingupon the direction along the device and support structure beingmeasured. In some further variations, the peak force may be at leastabout 0.02 Newtons per millimeter (N/mm), about 0.03 N/mm, about 0.05N/mm, about 0.1 N/mm, about 0.15 N/mm, about 0.2 N/mm, about 0.3 N/mm,about 0.4 N/mm or about 0.5N/mm. In some variations of devicescomprising generally flat or planar devices and support structureshaving a thickness, the peak force may be measured by applying acompressive force along the shortest dimension of the device/supportstructure that is transverse to the thickness of the device/supportstructure. According to such variations, the device may have an aspectratio of length to width that is greater than 1:1, 2:1 or 3:1, forexample.

A resistance to bending in the direction of dressing strain may also bemeasured by three-point bending, applying a transverse force to themidpoint of the applicator simply supported on two outer points at agiven distance apart or support span. For example, the distance betweenthe two points of a sample may be approximately 0.75 inches and a forcethat ranges from about 1 to 1.25 pounds may be applied to a sampleapproximately 0.35 inches in width resulting in a deflection ofapproximately 0.05 inches. A resistance to bending may also be measuredby characterizing the force at which buckling occurs on a simplysupported beam. For example, a force of approximately 0.45 pounds may beapplied to a simply supported sample approximately 0.35 inches in widthand may result in a deflection of approximately 0.004 inches. Theresistance to bending may also be characterized by the strain of theouter surface before fracture or permanent deformation. By takingmeasurements of the support structure and the deflections during thetest procedure, a load deflection curve may be generated and theflexural modulus of the support structure may also be calculated. Insome variations, the support structure may comprise a flexural modulusof at least about 0.9 GPa, while in other embodiments, the flexuralmodulus is at least about 1 GPa, at least about 1.1 GPa, at least about1.2 GPa, at least about 1.3 GPa, or at least about 1.4 GPa.

In another example, a device of 7 cm wide by 19 cm long may beconfigured with a support structure comprising a paperboard, supportsheet or support structure. The support structure may have an averagethickness in the range of about 0.008″ to about 0.028″ or greater. Insome specific variations, the support structure may have a thickness ofabout 0.012″, about 0.016″, about 0.018″, about 0.024″, about 0.28″ orabout 0.032″, about 0.036″, about 0.04″, about 0.05″ or greater. Uponthe application of force along the lengthwise edge of the 19 centimeterlength, i.e. across the 7 cm width of the device, the support structuremay provide sufficient rigidity or column strength to achieve peakforces of about 3 pound or more, 4 pounds or more, or of about 10 poundsor more, while being compressed, collapsed, bowed, buckled or otherwisedeformed by 25% along its 7 cm width (i.e. about 1.75 cm). In somevariations, the support structure may comprise scoring or regions ofreduced thickness to permit some bending it at least one direction or inboth directions.

According to some variations, a device that provides structural supportmay have a plurality or supporting cross elements or segments extendingfrom one edge of the length to an opposing edge or the length (or fromone edge of a width to an opposing edge of a width); According to somevariations there may be three or more cross elements, e.g., a crosselement extending along two opposing edges and transversely across awidth (or a length) and one or more cross elements extending across thewidth (or length) and between the cross elements along the two opposingedges. Such cross elements may or may not be coupled or connected toeach other, for example, with a relatively flexible material. Such crosselements may have a total aggregate width with respect to the length ofan opposing edge of about 20% or more, about 25% or more, about 30% ormore, or about 35% or more. According to some variations, one or morecross elements may be provided that have a total aggregate width,relative to the length of the opposing side, between about 20% to 100%.Such cross elements may be segmented and may provide flexibility whenbending in a direction and rigidity relative to the flexibility, inanother direction.

One or more devices or variations may also provide structural support orstability of the dressing as it is oriented and/or applied to the skinof a subject. According to some variations, the dressing and packagingis configured to be pre-oriented in a position facing a wound before orafter the wound device is prepared for application, e.g., the adhesiveliner is removed. According to some variations, a packaging orapplicator is configured to be used with one hand to orient and/or applythe device to the skin of a subject. For example, in some situations,particularly where a longer or larger dressing is used, a packaging orapplicator provides structural support for a dressing such that a usercan effectively hold onto, manipulate and/or apply a prepared dressingwith one-hand. According to some variations, the assembly may comprise asupport structure. A dressing support structure is defined herein tomean a structure that is coupled whether directly or indirectly, to aback surface of a dressing that is to be applied to a subject. Thesupport structure may further comprise at least in part, a material orstructure that is more rigid than the dressing to be applied to asubject. The support structure may comprise one or more elements orsegments. It may be constructed of a single substrate, a laminate or aplurality of elements coupled together and/or to the dressing. Accordingto some variations at least 20%, 25%, 30%, 35%, or 40% of a length orwidth of the dressing is supported by one or more support structuresextending from a first opposing side to an opposite side along a lengthor width of the dressing. In some further variations, the percentage ofa length or width that is supported by the support structure(s) is aminimum average of support across the entire length or entire width ofthe device, e.g. at least a 20%, 25%, 30%, 35% or 40% average supportacross an entire dimension of the device, e.g. length or width.According to some variations, an entire area of a dressing is supportedby a support structure. According to some variations, a base, carrier orsupport of a dressing may comprise at least three support structuresextending transversely between opposing sides of the dressing. Accordingto some variations, a support structure comprises interconnected membersor elements. According to some variations, a base, carrier or supportremains coupled to the dressing as it is applied. According to somevariations, greater structural support is provided to a dressingcarrier, support or base in a first direction while greater flexibilityis provided in a second direction, while lesser flexibility is in thefirst direction and lesser structural support is provided in the seconddirection. According to some variations, one or more support structuresmay extend beyond an edge of the first opposing side. According to somevariations, one or more support structures, at least in part, may extendbeyond at least a portion of an edge of a first opposing side and atleast in part beyond at least a portion of an edge of an opposite side.According to some variations, a support structure may extend at least 3mm from at least a portion of an edge of the dressing. According to somevariations, the packaging or applicator is configured to improve asterile transfer of a dressing to a wound of a subject. According tovariations, the packaging or applicator may be sufficiently wider orlonger, or have a sufficiently larger area than a dressing providing theability to maneuver or manipulate the support or applicator so that itprovides sterile application and/or one-handed application without theneed to touch the dressing. According to some variations, a margin ofdistance is provided from the outer edges of the dressing carrier,support or base to the dressing supported on the base or adhesive on thedressing. Such margins may be selected to prevent or resist a user fromtouching the dressing or dressing adhesive when grasping the edges tomanipulate the dressing carrier, support, applicator or base.

Devices, kits and methods described herein may be for the treatment,amelioration, or prevention of scars and/or keloids by creating and/ormaintaining a pre-determined strain in an elastic skin treatment devicethat is then affixed to the skin surface using skin adhesives totransfer a generally planar (e.g. compressive) force from the bandage tothe skin surface. Other uses include wound closure and skinsplinting/stabilization treatments.

In some variations, a dressing is provided, comprising an elastic sheetstructure (e.g., a comprising a silicone polyurethane, TPE(thermoplastic elastomers), synthetic rubber or co-polyester material)comprising an upper surface, a lower surface, a first edge and a secondedge opposite the first edge, and one or more adhesive regions. Thedressing may further comprise a first release liner releasably attachedto the adhesive region or regions. The adhesive region(s) may comprise apressure sensitive adhesive. The dressing may be tapered or otherwiseshaped to reduce skin tension at the edges. The dressing may havemodified, reduced or no adhesive near its edges to reduce skin tensionat the edges. Portions of the dressing may be unstrained and may therebyreduce strain in certain areas of the skin where the dressing isapplied. In some specific examples, the unstrained area or areas arefound between the edges of the dressing and the strained area(s). Insome further examples, the unstrained areas are limited to this area andare not found, during application or use, between the strained areas ofa single dressing, in use. In still further examples, the unstrainedareas are limited to areas along the edges of a dressing that intersectthe strain axis of the strained area(s), but not to areas along theedges of the dressing that are generally parallel to the strain axis.

A device may be used to strain and/or maintain a strain on a dressing.The device may further comprise a releasable locking mechanism,attachment mechanism or adhesive, configured to maintain the member ormechanism in a strained configuration.

According to some variations, the packaging is also sufficientlyflexible in at least one direction to permit curving or shaping of thedressing to conform to the curvature or shape of the location on thebody or skin where the dressing is applied. Generally, the flexibilityof the packaging used to conform the dressing to the treatment site maybe configured so that the treatment site is not substantially deformedduring the application of the dressing; so that the application of thedressing is relatively smooth or uniform on the skin; and/or provides auniform, predetermined, or relatively predictable strain or force to anarea of skin The packaging or applicator may have flexibility in a firstdirection and greater rigidity in another direction. The packaging orapplicator may include elements or segments that permit flexibility withrespect to adjacent elements or segments.

According to some variations, the packaging is also sufficientlyflexible in at least one direction to permit curving or shaping of thedressing to conform to the curvature or shape of the location on thebody or skin where the dressing is applied. Generally, the flexibilityof the packaging used to conform the dressing to the treatment site maybe configured so that the treatment site is not substantially deformedduring the application of the dressing; and/or so that the applicationof the dressing is relatively smooth or uniform on the skin; and/orprovides a uniform, predetermined, or relatively predictable strainand/or force to an area of skin. The packaging or applicator may haveflexibility in a first direction and greater rigidity in a seconddirection. The first direction may be transverse to the direction ofstraining or have a component that is transverse to the direction ofstraining. The second direction may by the direction of straining orhave a component that is in the direction of straining. The firstdirection may or may not be transverse with respect to the seconddirection. The packaging or applicator may include elements or segmentsthat permit flexibility with respect to adjacent elements or segments.

According to some variations a desired flexibility, for example havingat least one component transverse to the direction of straining, may becharacterized by a modified cantilevered beam bending model, i.e.applying a force to the free end of a beam, simply supported from theother end, while wrapping it around a cylindrical object with a knownradius of curvature or curvature, defined as the reciprocal of theradius of the curvature. According to one variation, the force to bendthe packaging or applicator around an object with a predeterminedcurvature may be no greater than about 3 pounds. According to onevariation, the force may be no greater than about 0.3 pounds. Accordingto one variation, the force to bend around a predetermined curvature ofabout a 2.5 inch radius may be no greater than about 3 pounds. Inanother variation, the force to bend around a predetermined curvature ofabout a 2.5 inch radius may be no greater than about 0.3 pounds.

In one variation, a skin treatment system is provided, comprising anelastic planar structure with a load per millimeter width of at least0.1 Newtons at a strain of at least 0.4, and a strain limiter coupled tothe elastic planar structure and configured to resist straining of theelastic planar structure beyond a predetermined strain. The strainlimiter may comprise a first handle at a first end of the at least onestrain limiter, and a second handle at a second end of the at least onestrain limiter. The skin treatment system may comprise at least twoelongate strain limiting structures. The first handle may becontiguously or non-contiguously coupled to the elastic planar structurebetween the first ends of the at least two elongate strain limitingstructures. The second handle may also be contiguously ornon-contiguously coupled to the elastic planar structure between thesecond ends of the at least two elongate strain limiting structures. Thepredetermined strain may be at least 0.2 or 0.4. The strain limiter maybe releasably coupled to the elastic planar structure. The strainlimiter may be adhered to the elastic planar structure using anadhesive. The adhesive may comprise a shear-resistance to a force levelthat is greater than the T-peel resistance to the force level. The firsthandle and the second handle may comprise a substantially inelasticmaterial relative to the elastic planar structure, which may optionallybe a semi-rigid or rigid material. The strain limiter may comprise atleast one flexible, inelastic elongate element. The elastic planarstructure may comprise an unstrained configuration in which a distancebetween a first attachment region of the strain limiter and a secondattachment region of the strain limiter is less than a length of thestrain limiter between the first attachment region and the secondattachment region, and may comprise a strained configuration at thepredetermined strain wherein the distance between the first attachmentregion of the strain limiter and a second attachment region of thestrain limiter is substantially equal to the a length of the strainlimiter between the first attachment region and the second attachmentregion. The strain limiter may comprise a folded board with at leastthree two folds, or a ratchet and pawl mechanism. The strain limiter maybe selectively configured to resist straining of the elastic planarstructure beyond a plurality of predetermined strains. The plurality ofpredetermined strains may comprise graphical indicia on the strainlimiter.

In another variation, the skin treatment system comprises an elasticplanar structure, comprising a tensioning axis, and a strain limitercoupled to the elastic planar structure and configured to resiststraining of the elastic planar structure beyond a predetermined strain,wherein the attachment of a first end of the strain limiter to theelastic planar structure is contiguous across a dimension of the elasticplanar structure transverse to the tensioning axis. The elastic planarstructure may have a load per millimeter width of at least 0.1 Newtonsat a strain of at least 0.4. The strain limiter may comprise a firsthandle at a first end of the at least one strain limiter, and a secondhandle at a second end of the at least one strain limiter. The skintreatment system may comprise at least two elongate strain limitingstructures. The first handle may be contiguously coupled to the elasticplanar structure between the first ends of the at least two elongatestrain limiting structures. The second handle may also be contiguouslycoupled to the elastic planar structure between the second ends of theat least two elongate strain limiting structures. The predeterminedstrain may be at least 0.2 or 0.4. The strain limiter may be releasablycoupled to the elastic planar structure. The strain limiter may beadhered to the elastic planar structure using an adhesive. The adhesivemay comprise a shear-resistance to a force level that is greater thanthe T-peel resistance to the force level. The first handle and thesecond handle may comprise a substantially inelastic material relativeto the elastic planar structure, which may optionally be a semi-rigid orrigid material. The strain limiter may comprise at least one flexible,inelastic elongate element. The elastic planar structure may comprise anunstrained configuration in which a distance between a first attachmentregion of the strain limiter and a second attachment region of thestrain limiter is less than a length of the strain limiter between thefirst attachment region and the second attachment region, and maycomprise a strained configuration at the predetermined strain whereinthe distance between the first attachment region of the strain limiterand a second attachment region of the strain limiter is substantiallyequal to the a length of the strain limiter between the first attachmentregion and the second attachment region. The strain limiter may comprisea folded board with at least three two folds, or a ratchet and pawlmechanism. The strain limiter may be selectively configured to resiststraining of the elastic planar structure beyond a plurality ofpredetermined strains. The plurality of predetermined strains maycomprise graphical indicia on the strain limiter.

In another variation, a skin treatment system is provided, comprising anelastic structure, first and second handles attached to opposite regionsof the elastic structure, wherein the first and second handles arecoupled to the elastic structure and configured to provide asubstantially uniform tensile force across the elastic structure; and astrain indicator. The strain indicator may comprises graphical ornumerical indicia of the degree of strain.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a top view of a skin treatment device in a firstconfiguration.

FIG. 1B is a top view of the skin treatment device of FIG. 1A in asecond configuration.

FIG. 2A is a top perspective view of a skin treatment device in a firstconfiguration.

FIG. 2C is a side elevational view of the skin treatment device in FIG.2A.

FIG. 2B is a top perspective view of a skin treatment device in astrained second configuration.

FIG. 3A is a top perspective view of a skin treatment device in arelatively unstrained configuration.

FIG. 3B is a top perspective view of the skin treatment device of FIG.2A in a first strained configuration.

FIG. 3C is a top perspective view of the skin treatment device of FIG.2A in a second strained configuration.

FIG. 4A is a top schematic view of a skin treatment device in a firstconfiguration.

FIG. 4B is a top schematic view of the skin treatment device of FIG. 4Ain a second strained configuration.

FIG. 5A is a top perspective view of a skin treatment device in a firstconfiguration.

FIG. 5B is a top perspective view of the skin treatment device of FIG.5A in a second configuration.

FIG. 6A is a top perspective view of a skin treatment device in a firstconfiguration.

FIG. 6B is a top perspective view of the skin treatment device of FIG.6A in a second, strained configuration.

FIG. 7A is a top perspective view of a skin treatment device in anunstrained configuration.

FIG. 7B is a bottom perspective view of the skin treatment device ofFIG. 7A in the unstrained configuration.

FIG. 7C is a top perspective view of a skin treatment device of FIG. 7Ain a strained configuration.

FIG. 7D is a bottom perspective view of the skin treatment device ofFIG. 7C in the strained configuration.

FIG. 8A is a top perspective view of a skin treatment device in anunstrained configuration.

FIG. 8B is a top perspective view of the skin treatment device of FIG.8A in a strained configuration.

FIG. 9A is a top perspective view of a skin treatment device in a firstconfiguration.

FIG. 9B is a top perspective view of the skin treatment device of FIG.9A in a second strained configuration.

FIG. 10A is a top perspective view of a skin treatment device in a firstconfiguration.

FIG. 10B is a top perspective view of the skin treatment device of FIG.10A in a second configuration.

FIG. 10C is a top perspective view of the skin treatment device of FIG.10A in a third strained configuration. FIG. 10A is a top perspectiveview of a skin treatment device in a first configuration.

FIG. 10D is a top perspective view of the skin treatment device in afirst configuration.

FIG. 10E is a top perspective view of the skin treatment device of FIG.10D in a second strained configuration.

FIG. 10F is a top perspective view of the skin treatment device of FIG.10D in a third strained configuration.

FIG. 10G is a top perspective view of the skin treatment device of FIG.10D in a fourth strained configuration.

FIG. 11A is top schematic view of a skin treatment device in a firstconfiguration.

FIG. 11B is a bottom schematic view of the skin treatment device of FIG.11A in the second configuration.

FIG. 11C is a top schematic view of the skin treatment device of FIG.11A in a second, strained configuration.

FIG. 11D is a bottom schematic view of the skin treatment device of FIG.11A in a second, strained configuration.

FIG. 12A is top schematic view of a skin treatment device in a firstconfiguration.

FIG. 12B is a bottom schematic view of the skin treatment device of FIG.12A in the second configuration.

FIG. 12C is a top schematic view of the skin treatment device of FIG.12A in a second, strained configuration.

FIG. 12D is a bottom schematic view of the skin treatment device of FIG.12A in a second, strained configuration.

FIG. 13A is a top perspective view of a skin treatment device in a firstconfiguration.

FIG. 13B is a top perspective view of the skin treatment device of FIG.13A in a second, partially strained configuration.

FIG. 13C is a top perspective view of the skin treatment device of FIG.13A in a third, strained configuration.

FIG. 14A is a top perspective view of a skin treatment device in a firstconfiguration.

FIG. 14B is a top perspective view of the skin treatment device of FIG.14A in a second, strained configuration.

FIG. 14C is a top perspective view of a the skin treatment device in afirst configuration.

FIG. 14D is a top perspective view of the skin treatment device of FIG.14C in a second, strained configuration.

FIG. 15A is a side perspective view of a tensioning device and skintreatment device prior to straining.

FIG. 15B is a side perspective view of the tensioning device of FIG. 15Astraining skin treatment device of FIG. 15B.

FIG. 16A is a side elevated view a dressing and tensioning device.

FIG. 16B is a top view of the dressing of FIG. 16A.

DETAILED DESCRIPTION

It is believed that controlling, managing or modulating stresses actingin and/or on skin (“mechanomodulation”) may have beneficial effects.Modulation of mechanical stresses or effects acting in and/or on skinmay translate into or induce biomechanical response, including but notlimited to, responses relating to scarring, scar proliferation or othereffects.

Devices, methods, systems and kits described herein may relate todevices used to shield skin or a wound from its mechanical environment.The term “shield” is meant to encompass the unloading of stressexperienced by the skin or wound as well as and/or providing a physicalbarrier against contact, contaminants, and the like. The stressshielding or force offloading devices and methods described here mayshield the skin or a wound by unloading endogenous stress and/orexogenous stresses. In some variations, the devices may shield the skinfrom endogenous stress without affecting exogenous stress on the skin,e.g., devices that modify the elastic properties of the skin, etc. Inother variations, the devices may shield the wound from exogenous stresswithout affecting endogenous stress on the skin wound. In still othervariations, the devices shield the skin from both endogenous andexogenous stress.

Devices, kits and methods described herein may treat skin at a skin site(“skin treatment device”), including without limitation, to amelioratethe formation of scars at wound sites by controllably stressing orstraining the epidermis and deeper layers of dermal tissue at or near askin site, i.e., at or adjacent a wound or treatment site of a subject'sskin, thereby reducing tensile or compressive stress at the skin site.The stress at the skin site may be reduced to levels below thatexperienced by normal skin and tissue. The stress or strain may beapplied to surrounding tissue in one, two, or more directions to reduceendogenous or exogenous stress at the skin site in one, two or moredirections. Thus, devices and methods described herein may reduce thestress experienced by skin and/or a wound and surrounding tissues inorder to treat a subject. The device may also assist in preventing orreducing the incidence of wound dehiscence.

“Dressing” or “Skin Device” as used herein may include but is notlimited to, a skin treatment device, wound treatment device, scar orkeloid treatment device, scar or keloid amelioration or preventiondevice, bandage, or dressing, that may be applied, attached to orcoupled to one or more layers of the skin or tissue of a subject.

Devices kits and methods described herein may be for the preparationand/or application of a dressing. Such preparation may include but isnot limited to, for example, removal of an adhesive liner, straining ortensioning a dressing, orienting a dressing for application and/orapplying a medicament or other material to a portion of the dressingprior to application.

According to some variations, the packaging, tensioning device, dressingcarrier, support, base, handles, manipulation elements and/or applicatormay further comprise an opening, a window, or a clear or semi-opaqueportion through which a wound, incision or other location may bevisualized as the dressing is applied to the skin. According to somevariations, the window guides the application of a dressing so thatthere is an optimal or desired distance between the wound and the edgesof the dressing and/or so that the dressing is in an optimal locationfor unloading skin stresses.

According to some variations, a packaging, manipulation element, and/orapplicator is more rigid or provides sufficient column strength in atleast a first direction to be supportive of a dressing, while beingrelatively more flexible and less rigid in at least second direction toprovide for a more conforming application to a curved or shaped skinsurface of a subject or to permit curvature or shaping of the dressingwhere it is applied. The first and second directions may or may not beorthogonal to each other. According to some variations, a packagingapplicator, tensioning device or dressing carrier, support or base issufficiently rigid or supportive of a dressing while permitting shapingof the dressing. According to some variations, the carrier or supportwhich may include a base and/or a cover may comprise segments ofrelatively more rigid material flexibly coupled to adjacent segments toprovide flexibility to permit shaping of packaging/applicator and/ordressing while providing sufficient support of the dressing duringapplication. According to some variations, segments are coupled toadjacent segments by way of a flexible material, such as a low-densitypolyethylene (LDPE) material, or a composite of adhesive and a thinnermore flexible substrate. Alternatively, segments may be formed as astructure by manufacturing a substrate with cut-outs, slots, grooves,scoring or other openings or variations in thickness of the substrate atdifferent locations.

The packaging, applicator, manipulation elements tensioning device, ordressing carrier may have elements or features the provide flexibilityin one direction while limiting flexibility in another direction. Eachof the elements may permit flexing in a different direction than one ormore of the other elements. Flexible elements may be straight, or shapedaccording to a desired application or location of placement. Accordingto some variations, the flexible elements may limit flexibility when thedevice is being strained and permit flexibility when the device is beingapplied to the skin.

According to variations, flexible elements are provided in combinationwith support elements that provide sufficient support to allow a user tomaintain the dressing in a strained configuration. According tovariations, one or more elements may be provided to maintain a straineddressing in a strained configuration, for example a securing elementthat secures the dressing in a strained configuration until it isapplied to a subject and is released from the carrier, support, base,manipulation element, tensioning device or applicator. For example,after straining the dressing, the dressing may be adhered or attached toone or more elements of a dressing, support, base, manipulationelements, tensioning device or applicator or dressing assembly until itis released from the carrier, support, base tensioning device orapplicator or assembly.

According to some variations, the applicator may be further used to helpreduce bleeding, e.g., by allowing application of a compressive forceusing a support structure while or after the device is applied. One ormore hemostatic or coagulative agents may be applied to, or otherwiseintegrated with dressing to help reduce bleeding. Potential agentsinclude chitosan, calcium-loaded zeolite, microfibrillar collagen,cellulose, anhydrous aluminum sulfate, silver nitrate, potassium alum,titanium oxide, fibrinogen, epinephrine, calcium alginate, poly-N-acetylglucosamine, thrombin, coagulation factor(s) (e.g. II, VII, VII, X,XIII, Von Willebrand factor), procoagulants (e.g. propyl gallate),antifibrinolytics (e.g. epsilon aminocaproic acid), and the like. Insome variations, the agents may be freeze-dried and integrated into thedressing and activated upon contact with blood or other fluid. In somefurther variations, an activating agent may be applied to the dressingor the treatment site before the dressing is used on the subject. Instill other examples, the hemostatic agent may be applied separately anddirectly to the wound before application of the dressing, or afterapplication to the dressing via a catheter or tube. The devices may alsocomprise one or more other active agents that may be useful in aiding insome aspect of the wound healing process. For example, the active agentmay be a pharmaceutical compound, a protein (e.g., a growth factor), avitamin (e.g., vitamin E), or combinations thereof. A further example ofsuch medicament may include, but is not limited to various antibiotics(including but not limited to cephalosporins, bactitracin, polyxyxin Bsulfate, neomycin, polysporin), antiseptics (such as iodine solutions,silver sulfadiazine, chlorhexidine), antifungals (such as nystatin),antiproliferative agents (sirolimus, tacrolimus, zotarolimus, biolimus,paclitaxel), grow factors (such as VEGF) and other treatments (e.g.botulism toxin. Of course, the devices may comprise more than onemedicament or agent, and the devices may deliver one or more medicamentsor agents.

The dressing may comprise an elastic member, such as a sheet of elasticmaterial. The elastic material of the dressing may comprise a singlelayer of material or multiple layers of the same or different materials.The material may have any of a variety of configurations, including asolid, foam, lattice, or woven configuration. The elastic material maybe a biocompatible polymer, e.g., silicone, polyurethane, TPE(thermoplastic elastomers), synthetic rubber or co-polyester material.The thickness of polymer sheets may be selected to provide the dressingswith sufficient load carrying capacity to achieve desired recoverablestrains, and to prevent undesired amounts of creep deformation of thedressings over time. In some variations, the thickness across dressingsis not uniform, e.g., the thickness across the dressing may be varied tochange the stiffness, the load carrying capacity, or recovery strains inselected orientations and/or locations. The elastic material of theexemplary dressing may have a thickness in the range of about 50 micronsto 1 mm or more, about 100 microns to about 500 microns, about 120microns to about 300 microns, or in some variations about 200 microns toabout 260 microns. The exemplary dressings have an edge thickness ofabout 500 microns or less, 400 microns or less, or about 300 microns orless may exhibit less risk of skin separation from inadvertent liftingwhen inadvertently brushed against clothing or objects. In somevariations, the dressings are tapered near the edges to reducethickness. A tapered edge may also ameliorate peak tensile forces actingon skin tissue adjacent to the adhesive edges of the dressing. This mayor may not reduce the risk of skin blistering or other tension-relatedskin trauma. In other variations, the edges of the dressing may bethicker than the middle of the dressing. It is hypothesized that in someconfigurations, a thicker dressing edge may provide a relative inwardshift of the location of the peak tensile forces acting near thedressing edge, compared to dressings of uniform thickness. The elasticmaterial may have a load per width of at least 0.35 Newtons per mm at anengineering strain of 60% or a load per width of at least 0.25 Newtonsper mm at an engineering strain of 45%. The elastic material may have aload per width of no greater than about 2 Newtons per mm at theengineering strain of about 45% to 60%, about 1 Newtons per mm at theengineering strain of about 45% to 60%, about 0.7 Newtons per mm at theengineering strain of about 45% to 60%, or no greater than about 0.5Newtons per mm at the engineering strain of about 45% to 60%. The systemelastic material may have a load per width that does not decrease froman engineering strain of 0% to 60%, a load per width plot that increaseslinearly from an engineering strain of 0% to 60%, or a load per widthplot that is not convex from an engineering strain of 0% to 60%. Theelastic material may comprise an adhesive configured to maintain asubstantially constant stress in the range of 200 kPa to about 500 kPafor at least 8 hours when strained to an engineering strain of about 20%to 30% and attached to a surface. The elastic material may comprise anadhesive configured to maintain a substantially constant stress in therange of 200 kPa to about 400 kPa for at least 8 hours when strained toan engineering strain of about 20% to 30% and attached to a surface. Thesubstantially constant stress may vary by less than 10% over at least 8hours, or by less than 5% over at least 8 hours.

Although the depicted dressings may have a generally rectangularconfiguration with a length and/or width of about 160 mm to about 60 mm,in other variations the dressing may have any of a variety of lengthsand widths, and may comprise any of a variety of other shapes. Also, thecorners of the dressing may be squared or rounded, for example. Thelengths and/or widths of an exemplary dressing may be in the range ofabout 5 mm to about 1 meter or more, in some variations about 20 mm toabout 500 mm, and in other variations about 30 mm to about 50 mm, and instill other variations about 50 mm to about 100 mm. In some variations,the ratio of the maximum dimension of the dressing (e.g. its length) toan orthogonal dimension to the maximum dimension (e.g. width), excludingthe minimum dimension of the dressing (e.g. the thickness), may be inthe range of about 1:3, about 1:2, about 1:1, about 2:1, about 3:1,about 4:1 about 5:1, about 6:1, about 7:1, about 8:1, about 9:1 or about10:1 or greater. In some variations, the strain axis of the dressing inuse may be oriented with respect to the maximum dimension or to theorthogonal dimension to the maximum dimension. In some variations, thefinal compressive stress and strain imposed onto the skin by the elasticmaterial may be the result of the dynamic equilibrium between thetensile stress in the skin and the elastic material of the dressing. Theskin at the skin site typically comprises an inherent tension thatstretches incision site, whether or not any tissue was excised from theskin site. The elastic material and the adhesive region may beconfigured to be applied to a skin location so that when the dressing isstretched to a particular tension and then adhered to the incision site,tensile stress in the dressing is transferred to the incision site tocompress the tissue directly under the dressing along a tangential axisto the skin surface, the stress and strain imposed onto the skinlocation has a net or resultant orientation or axis is also generallytangential or planar to the elastic material and/or the outer surface ofthe skin location, with a similar axis to the orientation or axis of thetensile stress in the dressing. The tension in the dressing will relaxto a tension level that maintains equilibrium with increased tension inthe skin adjacent to the dressing. The application of the dressing tothe skin location may involve the placement of the dressing withoutoverlapping or being wrapped onto itself, e.g. wherein only adjacentregions of the dressing are interconnected and wherein non-adjacentregions of the dressing are not interconnected. The actual amount ofstress and strain imposed on the skin may vary, depending upon theparticular person, skin location, the thickness or various mechanicalcharacteristics of the skin layers (e.g. epidermis, dermis, orunderlying connective tissues), and/or the degree of pre-existingscarring, for example. In some further variations, the wound treatmentdressing may be selected or configured for use at a specific bodylocation, such as the scalp, forehead, cheek, neck, upper back, lowerback, abdominal region, upper torso (including but not limited to thebreast folds), shoulder, upper arm, lower arm, palm regions, the dorsumof the hand, finger, thigh, lower leg, the dorsum or plantar surface ofthe foot, and/or toe. Where applicable, some body regions may be furtherdelineated into anterior, posterior, medial, lateral, proximal and/ordistal regions, e.g. the arms and legs.

The dressing may be configured to impose a skin strain in the range ofabout 10% to about 60% or more, in other configurations about 15% toabout 50%, and in still other configurations, about 20% to about 30% orabout 40%; the dressing may also be configured to impose a strain ofless than 10%. To achieve the desired degree of skin strain, thedressing may be configured to undergo elastic tensile strain in therange of about 20% to about 80% or more, sometimes about 30% to about60%, and other times about 40% to about 50% or about 60%. The dressingmay comprise any of a variety of elastic materials, including but notlimited to silicones, styrenic block copolymers, natural rubbers,fluoroelastomers, perfluoroelastomers, polyether block amides,thermoplastic elastomers, thermoplastic polyurethane, polyisoprene,polybutadiene, and the like. The material of the exemplary dressing mayhave a Shore A durometer in the range of about 20 to about 90, about 30to about 80, about 50 to about 80. The exemplary dressing wasconstructed of MED 82-5010-05 by NUSIL TECHNOLOGY LLC (Carpinteria,Calif.). Other examples of suitable materials are described in U.S.application Ser. No. 11/888,978, which was previously incorporated byreference in its entirety.

When the dressing is applied to a skin location and allowed to at leastpartially recover to its base configuration, the recovery level orequilibrium level of strain in the dressing may be in the range of about4% to about 60% or more, in other configurations about 15% to about 50%,and in still other configurations, about 20% to about 30% or about 40%.The ratio between the initial engineering tensile strain placed onto thedressing before recovery and the resulting engineering compressivestrain in the skin may vary depending upon the skin type and location,but in some examples, may be about 2:1. In other examples, the ratio maybe in the range of about 4:1 to about 5:4, about 3:1 to about 5:3, orabout 5:2 to about 2:1. These skin strain characteristics may bedetermined with respect to a reference position of the body or bodypart, e.g. anatomical position, to facilitate reproducible measurements.The particular degree of strain may be characterized as either anengineering strain or a true strain, but may or may not be calculatedbased upon or converted from the other type of strain (e.g. the strainmay be based upon a 45% engineering strain that is converted to a truestrain).

In some further variations, one or more characteristics of the elasticmaterial may correspond to various features on the stress/strain curveof the material. For example, the engineering and true stress/straincurves for one specific example of the dressing comprises a materialthat exhibits an engineering stress of about 1.2 MPa at about 60%engineering strain, but in other examples, the engineering stress may bein the range of about 900 KPa to about 3.5 MPa, about 1 MPa to about 2.2MPa, about 1 MPa to about 2 MPa, about 1.1 MPa to about 1.8 MPa, about1.1 MPa to about 1.5 MPa, about 1.2 MPa to about 1.4 MPa. When unloadingor relieving stress from the dressing, the material may be configuredwith an engineering stress of about 380 KPa at about 40% engineeringstrain, but in other examples, the engineering stress during unloadingof the material to about a 40% strain may be in the range of about 300KPa to about 700 KPa, about 325 KPa to about 600 KPa, about 350 KPa toabout 500 KPa, or about 375 KPA to about 425 KPa. When unloading thematerial to an engineering strain of about 30%, the material exhibits anengineering stress of about 300 KPa, but in other examples, theengineering stress when unloading the material to about 30% strain maybe in the range of about 250 KPa to about 500 KPa, about 275 KPa toabout 450 KPa, about 300 KPa to about 400 KPa, or about 325 KPA to about375 KPa. When unloading to an engineering strain of about 20%, thematerial may have an engineering stress of about 100 KPa, but in otherexamples, the unloading engineering stress at about 20% may be in therange of about 50 KPa to about 200 KPa, about 75 KPa to about 150 KPa,or about 100 KPa to about 125 KPa. In some examples, the material may beconfigured to at least achieve a specific range or level of engineeringstress at each of the specified engineering strain levels describedabove, but in other examples, the material may be configured for lowerlevels of maximum engineering strain, e.g. up to about 30% or about 40%.

In some examples, certain portions of the stress/strain curve may have aparticular morphology. For example, for a particular level of maximumstrain the loading curve may be generally linear on the correspondingtrue stress/strain curve. In an example using a dressing describedherein, up to a true strain of about 45%, the loading curve had agenerally linear configuration. In other examples, the configuration mayonly be linear along a portion of the loading curve or may be curvedalong the entire loading curve. Where the loading curve is non-linear,the loading curve may be convex, concave or both. Also, in someexamples, the tangent line of the loading curve (i.e. the line betweenthe two triangles) may also be generally co-linear.

In some variations, the elastic material comprises a material having anelastic modulus E of at least about 1 MPa, about 1.5 MPa, about 2 MPa,about 2.5 MPa, about 3 MPa, about 3.5 MPa, about 4 MPa, about 5 MPa,about 6 MPa, about 7 MPa, about 8 MPa, about 9 MPa or at least about 10MPa or greater. The material elastic modulus E may be no greater thanabout 10 MPa, about 9 MPa, about 8 MPA, about 7 MPa, about 6 MPa, orabout 5 MPa, or about 4 MPa.

In addition to the absolute stress levels at certain strain levelsdescribed above, the material may also be characterized with respect tothe ratio between a) the stress to achieve a particular strain duringloading, and b) the stress at the same strain during unloading. Forexample, the material may have a ratio of at least 4:1 to about 3:2 ateach of the 20%, 30% and 40% strain levels, but in other examples, thematerial may exhibit these ratios only at 20%, at 30%, or at 40% strainlevels, or at both 20% and 30% but not 40%, or at both 30% and 40% butnot 20%. In other examples, the ratio at one, some or all of the strainlevels may be in the range of about 3:1 to about 2:1, or about 5:2 toabout 2:1.

In some examples, the elastic material of the dressing may be configuredunder testing conditions to achieve a stable level of stress at aconstant strain, e.g. the material exhibits a limited amount of stressrelaxation over a particular period of time and at a particular level ofstrain. The period of time may be at least about 8 hours, about 12hours, about 18 hours, about 24 hours, about 36 hours, about 48 hours,about 72 hours, about 4 days, about 5 days, about 6 days, or about aweek or more. The level of strain may be about 10%, about 20%, about30%, about 40%, about 50%, about 60%, about 70%, or about 80% or more.The stress of the exemplary dressing over various time curves may beconfigured to maintain an engineering stress of about 300 KPa at anengineering strain of about 30% without noticeable deviation over aperiod of about 1 hour, about 2 hours, about 3 hours, about 4 hours,about 5 hours, about 6 hours, about 7 hours, or about 8 hours or more.The stresses at 10% strain, 20% strain, and at 40% may be lower orhigher.

In some variations, the elastic material or the dressing may beconfigured under testing conditions to maintain a particular minimumlevel of stress when held at a constant strain over a particular timeperiod. In an example to assess the ability of a backing material tomaintain a stress and strain on skin over time, engineering strains weremeasured while each backing material was tensile strained to 60% at arate of 100 microns per second and held for 10 minutes, and then droppedto a strain of 30% at a rate of 100 microns per second and held for 9hours. For example, the exemplary dressing is able to maintain anengineering stress level of about 350 KPa at an engineering strain of30%. In some other examples, the minimum level of stress may be about100 KPa, about 120 KPa, about 140 KPa, about 160 KPa, about 180 KPa,about 200 KPa, about 220 KPa, about 240 KPa, about 260 KPa, about 280KPa, about 300 KPa, about 320 KPa, about 340 KPa, about 360 KPa, about380 KPa, about 400 KPa, about 420 KPa, about 440 KPa, about 460 KPa,about 480 KPa, about 500 KPa, about 600 KPa, about 700 KPa, about 800KPa, about 900 KPa or about 1000 KPa or greater. The level of constantstrain may be different in other configuration, with a level of about15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%,about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, orabout 80%. The time period over which the dressing is able to maintain astress level may be at least about 2000 seconds, about 3000 seconds,about 4000 seconds, about 5000 seconds, about 6000 seconds, about 7000seconds, about 8000 seconds, about 9000 seconds, about 10000 seconds,about 20000 seconds, about 30000 seconds, about 40000 seconds, about50000 seconds, about 60000 seconds, about 70000 seconds, about 24 hours,about 36 hours, about 48 hours, about 72 hours, about 4 days, about 5days, about 6 days, about 7 days, about 10 days, about 2 weeks, about 1month or more. In some variations, the dressing, the elastic materialand/or the adhesive material is configured to exhibit less than about a15% change in stress or strain level over the particular period whenapplied to a skin surface or test surface. In other examples, the degreeof change may be about 12%, about 10%, about 8%, about 6%, about 5%,about 4%, about 3%, or about 2% or less. The stress or strain may be anengineering stress or strain, and/or a true stress or strain.

The adhesive used may be, for example, a pressure activated adhesive(PSA), as a silicone, acrylic, styrene block copolymer, vinyl ether,nitrile or other PSA. In other variations, a non-pressure sensitiveadhesive may be used, including but not limited a heat or light-curedadhesive. The pressure sensitive adhesive may be made from, e.g.,polyacrylate-based, polyisobutylene-based, silicone-based pressuresensitive adhesives, synthetic rubber, acrylic, and polyisobutylene(PIB), hydrocolloid, and the like. The T-peel release force and bluntprobe tack force of the adhesive may be measured by a standardized testmethod, such as ASTM D1876 and ASTMD2979 or other appropriate method. Insome variations, the T-peel release force or blunt probe tack test valueof the adhesive is configured to maintain loads of at least about 50mPa/mm for at least about 24 hours, about 48 hours, about 72 hours,about 1 week, about 2 weeks, about 3 weeks, about 4 weeks or more. Inother variations, the loads may be at least about 75 mPa/mm, about 100mPa/mm, about 125 mPa/mm, or at least about 150 mPa/mm over theparticular time period. The degree of adhesion (e.g. as measured by theT-peel release force or blunt probe tack test value) may vary dependingupon the degree of strain placed onto the skin or incision site, and insome variations, these time periods may be based upon an average skinstrain of about 10%, about 20%, about 30%, about 40%, or about 50% ormore. In some variations, the adhesive may have a T-peel release forceof at least about 150 kg/m, about 160 kg/m, about 170 kg/m, about 180kg/m, about 190 kg/m, about 200 kg/m, about 210 kg/m, about 220 kg/m,about 230 kg/m, about 240 kg/m, about 250 kg/m, about 260 kg/m, about270 kg/m, about 280 kg/m, about 290 kg/m, about 300 kg/m, about 310kg/m, about 320 kg/m, about 330 kg/m, about 340 kg/m, about 350 kg/m,about 400 kg/m, about 450 kg/m, or at least about 500 kg/m or higher. Insome further variations, the T-peel release force may be no greater thanabout 1000 kg/m, about 900 kg/m, about 800 kg/m, about 700 kg/m, about600 kg/m, about 500 kg/m, about 400 kg/m or about 300 kg/m. The bluntprobe tack test value of the adhesive may be at least about 0.50 kg,about 0.55 kg, about 0.60 kg, about 0.65 kg, about 0.70 kg or about 0.75kg or higher, and may be no greater than about 1 kg, about 0.9 kg, about0.8 kg, about 0.7 kg, or about 0.6 kg. The T-peel release force andblunt probe tack force may be measured by a standardized test method,such as ASTM D1876 and ASTMD2979 or other appropriate method. Otherfeatures or variations of the device are described in U.S. applicationSer. No. 11/888,978, filed on Aug. 3, 2007, incorporated in its entiretyherein by reference.

Release liners may be provided over the skin adhesive and may be removedprior to stressing, straining, stretching and/or applying a dressing toa subject. The release liners may comprise any of a variety ofmaterials, including both opaque and transparent materials. The releaseliners may comprise Mylar or paper, or any other material with reducedadhesion to the adhesive material(s) of the device. For example, for asilicone adhesive, a fluoropolymer-treated polyester film may be used,and for an acrylic pressure sensitive adhesive, a silicone treatedpolyester or Mylar film or silicone treated craft paper may be used. Invariations where the device has multiple separate adhesive regions,separate release liners may be provided for each region, or some regionsmay be covered by the same release liner.

In some variations the assembly may comprise one or more mechanisms orelements configured to facilitate separation, release, removal ordetachment of the dressing from the packaging, manipulation elementsapplicator or tensioning device, other attachment elements or otherportions of the dressing assembly, or other elements of the devices.Release elements or releasable attachment structures may include but arenot limited to pockets and tabs, hook and loop mechanism, hooks, angledbars, pivoting, rolling, rocking or sliding features associated with orcoupled to attachment structures, adhesives, removable adhesives,adhesive tapes or other adhesive devices, pegs, rip cords, towel barconfigurations, sliding pins, friction locks, cam locks, vacuum orsuction devices, snap connectors, carpet tack, press fit connections orother connections, levers, latches, locking members, spring members, forexample, or other mechanisms such as cutters or rip cords or otherstructures or features to facilitate tearing, cutting or separation ofattachment structures or elements perforated or otherwise severablestructures, that permit removal of dressing from the applicator,packaging, other portions of the dressing assembly and/or attachmentstructures, features, elements or portions. They may be self-releasinglatches or spring members. They may be actuated when a pressure memberis applied to a skin treatment device prior to removing the applicator.They may be manually actuated.

Packaging devices, applicators, tensioning devices, and correspondingattachment features may be configured to provide multi-direction strainor additional strain in an orthogonal direction to a dressing.

The packaging device, manipulation elements, applicator, tensioningdevice and/or attachment structure profile may be straight, curved orotherwise varied. For example, the shape of the elements of a device maybe configured to follow the shape of the area of the subject's body towhich the skin treatment device is to be attached. A packaging device,manipulation elements, tensioning device, applicator or other elementsthereof may be selected or configured to have a profile that has adesirable profile for a particular body location or profile where theskin treatment device is to be placed on a subject's skin. A packagingdevice, manipulation element, applicator, tensioning device or elementsthereof may be selected or configured to closely match a portion of asubject's body profile. The packaging device, manipulation element,applicator or tensioning device and/or an element or segment thereof,may be curved, curvable, flexible, bendable, malleable, deformable,shapeable or movable to provide alternative shapes or profiles of anattached dressing. They may be relatively curved, curvable, flexible,malleable, bendable, deformable, shapeable or movable in at least onedirection while being more rigid in another direction.

A variety of locking, latching, securing, attaching or detent mechanismsmay be used to maintain the dressing, packaging, manipulation elements,applicator and/or tensioning device in a various configurationsincluding but not limited to unstrained, partially strained, strainedconfigurations. A variety of locking, latching or detent mechanisms maybe used to maintain a dressing in a variety of configurations includingunstrained, partially strained, strained. By locking the packaging,applicator, tensioning device manipulation elements or other elementscoupled to the dressing, or dressing in a strained position, apredetermined strain of a given dressing may be achieved and maintaineduntil released. The predetermined amount of strain may be apredetermined absolute percentage of strain or level of force that isindependent of the shape and/or size of the treatment site.

According to a variation, a skin treatment device is provided that maybe strained prior to application to the skin of a subject. According tovariations, device or device elements may provide a variable strain tothe skin treatment device.

According to variations, a skin treatment device may comprise one ormore manipulation elements removably coupled to a dressing. Suchvariations may further comprise a strain limiter that limits ordetermined the amount of strain applied to a dressing. Such variationsmay also further comprise a strain indicator that indicates a desiredstrain level has been reached. A

According to a variation, a plurality of strain indicators may beprovided where each indicator indicates a different strain level oramount.

According to a variation, a skin treatment device is provided that maybe strained by a user prior to application to the skin of a subject.According to a variation, skin treatment device may include strainindicator that indicates when the dressing has been stretched by theuser to a desired degree.

According to a variation, a skin treatment device that may be strainedby a user may include a strain limiter configured to prevent overstraining of the device, or straining the device beyond a desired degreeor amount.

According to a variation, the strain limiting elements may preventstraining in regions where straining or less strain is desired. Thestrain limited skin treatment devices may also be shaped to provide agraduated strain or varying strain through the strained device. Thedevice may be stretched by hand or may otherwise be configured to bestretched with a tensioning device, for example a set forth inapplication Ser. Nos. 12/854,859 and 13/345,524 incorporated in theirentirety herein by reference.

According to a variation, a skin treatment device comprises one or morerelaxed threads, strings, wires or other elongate, elongatable,straightenable or stretchable members that straighten, lengthen and/orstretch to a desired amount, degree, and/or preset limit. For example,in one variation, the members may have an undulating shape when the skintreatment device is unstretched and a straight configuration when theskin treatment device is stretched to a desired degree. The members mayhave a sufficient tensile strength to prevent over-stretching of theskin treatment device. According to a variation the skin treatmentdevice is constructed of multiple layers of an elastic material such assilicone with an adhesive between layers to which the members areattached initially in the relaxed, undulating, sinusoidal,unstraightened or other unstretched configuration. According to avariation, the shape limiting strings or other devices may preventstraining in regions where straining or less strain is desired. Forexample, the threads may be straight at the edges of the skin treatmentdevice to prevent straining at the edges.+−

FIGS. 1A and 1B illustrate a strainable skin treatment device 110 withstrain indicators and/or strain limiters 150. The strain indicatorsand/or limiters 150 may be visibly positioned in or on a device assembly108 which may comprise layers of elastic material sandwiching the strainindicators 150 therebetween. The material may or may not be transparentor translucent. Indicators may also be positioned on the surface of thedevice. The strain indicators and/or limiters 150 may be threads, wiresor other elongate or elongatable members 155. In use, the deviceassembly 108 is grabbed by a user at opposing sides 114, 115 andstretched. The opposing sides 114, 115 may also have removable (ornon-removable) manipulation elements attached to the ends to provide fora more even or uniform strain, and may comprise an inelastic materialwhich is the same or different as the strain indicators/limiters 150.The manipulation elements may span the entire transverse dimension ofthe device 110 to the axis of tensioning, as depicted in FIG. 1B, but inother variations may be less than the entire transverse dimension (e.g.having a transverse dimension sufficient to span a plurality of strainindicators/limiters 150, but less than the full transverse dimension ofthe device 110). Such elements may comprise planar members, handlemembers, flexible members and/or inflexible members. They may beattached and removed in a variety of manners, for example as describedherein. Also, although the example depicted in FIGS. 1A and 1B depict aplurality of strain indicators/limiters 150 that are equally spacedapart and have uniform lengths and uniform attachment points across atransverse dimension to the tensioning axis of the device 110, in otherexamples, the indicators/limiters 150 may have a variable or non-uniformspacing, may have non-uniform lengths, non-uniform attachment points,and may also be serially arranged along the tensioning axis.

As the skin treatment device 110 is stretched or strained, the devicewidth increases and the members 155 straighten. When the skin treatmentdevice 110 has been stretched or strained to a desired amount or apre-determined or preset amount, the indicators and/or limiters 150 arein a visible or identifiably straightened configuration, for example asshown in FIG. 1B. The indicators and/or limiters 150 may also comprise arelatively inelastic material such as, e.g. a nylon string, thatprevents or resist the skin treatment device 110 from over stretching orstraining to a degree greater than is desirable, thus limiting thestrain applied to the device 110. A skin adhesive with a protectiveliner may be applied to a side of the skin treatment device 110 prior tostretching, stressing or straining. The liner may be removed from theskin treatment device 110 prior to stretching. According to one aspectof the invention, it is believed that a range of strain is significantin providing treatment to a skin. According to variations other shapesor stretching indicators may be used where a visible change in anindicator line, shape or color may occur. Examples of a color changematerial or structure are described in U.S. Pub. No. 2006/0246802 toHughes et al, which is herein incorporated by reference in its entirety.

FIG. 2A to 2C illustrate a manually strainable skin treatment device 200that may comprise, an elastic material. The skin treatment device 200 iscoupled to a strain limiting backing 210 comprising a flexible inelasticor relatively less elastic material with respect to the elastic materialof the skin treatment device 200, such as, for example, LDPE, FEP ornylon. As shown in FIG. 2A, prior to straining, the skin treatmentdevice 200 is shown in a relaxed, folded configuration, coupled (e.g.with an adhesive such as a preferentially removable adhesive as comparedto skin adhesive used on surface 204) at its opposing ends 201, 202 tothe inner surface 214 of the strain limiting backing 210 at locations orareas 211,212. In the relaxed configuration the length of the device 200is a first shorter length. The ends 216, 217 of the strain limitingbacking 210 may extend outward of locations 211, 212 and be used asgrips to pull and straighten the backing 210 as shown in FIG. 2A tothereby strain and increase the length of the device 200 to a secondgreater length. The inner surface 214 of the strain limiting backing maycomprise an adhesive layer such as a preferentially removable adhesiveas compared to skin adhesive used on surface 204 which may attach theback 203 of the device 200 to the inside surface 214 of the backing 210when the device is strained. The exposed surface 204 of the device 200may comprise a skin adhesive such as a pressure sensitive adhesive thatsecures the device to a skin surface when applied. After the device isapplied to a skin surface, the backing 210 may be peeled away from thedevice 200.

FIGS. 3A to 3C illustrate a strainable skin treatment device 300 whichmay be strained and/or stretched by exerting a tensioning force on theends 307, 308 of the skin treatment device 300. A first opposing slidingelement 305 is coupled at its end 317 to the first end 307 of the device300 and a second opposing sliding element 306 is coupled at its end 316to the second end 308. The sliding elements 305 may be removable coupledto the skin device 300, for example with an adhesive such as apreferentially removable adhesive as compared to skin adhesive used onskin interfacing surface. The first sliding element 305 and secondsliding element 306 are slidably coupled to each other. The firstsliding element 305 comprises a window 311 and securing bar 312. Thesecond sliding element 306 comprises an elongate tab 309 having strainvalue indicators 310 on the top surface of the elongated tab 309 so thatthey may be viewed through window 311. The tab 309 of the second slidingelement 306 is positioned under the first sliding element 305 andthrough the window 311 of the first sliding element 305. The securingbar 312 is positioned across the window 311 and below the tab 309, tohold the tab 309 in position through the window 311. Additional securingelements such as rails or guide elements may or may not be used to guideor maintain connection or alignment of the tab 309 with respect to thewindow 311. The ends 306, 307 and/or ends 316, 317 may be used to gripand strain the device 300, and may or may not comprise an inelasticmaterial. As the skin treatment device 300 is strained, the elements305, 306 slide apart and the tab 309 slides through the window 311. Inthe first position in FIG. 3A, the device is at a 0% strain in a firstunstrained configuration. In FIG. 3B, the device 300 is strained about25% as indicated by the strain indicator 310. In FIG. 3C the device isstrained to 45% as indication by the indicator 310. A user may selectthe amount of strain desired. A user may use the indicators 310 tostrain the device 300 to a desired degree. A skin adhesive may beprovided on the skin attachment side 314 of the device 300. The ends316, 317 may be attached to the top surface 318 (opposing a skinadhesive surface) of the device 300 by way of an adhesive, such as apreferentially removable adhesive as compared to skin adhesive usedonskin adhesive surface After straining the device 300 a desired amount,it may be placed on a skin surface and the manipulation elements orsliding members 316, 317 may be removed. Alternatively, one of the sides307 or 308 of the device may be applied to a skin surface. The device300 may be strained a desired degree by pulling on the on the unattachedone of the sides 307 or 308 while observing the indicia 310. Once adesired strain level is reached the unattached side 307 or 308 may beattached to the skin and the manipulation elements or sliding members316, 317 may be removed

FIGS. 4A and 4B illustrate a strainable skin treatment device 400 whichmay be strained and/or stressed by exerting a tensioning force on theends 407, 408 of the skin treatment device 400. A ratchet 404 comprisesfirst opposing ratchet element 405 coupled at its end 417 to the firstend 407 of the treatment device 400, and a second opposing ratchetelement 406 coupled at its end 418 to the second end 408 of thetreatment device 400. Ratchet elements 405, 406 are movably coupled toeach other so that they may be separated and the device may be tensilestressed and maintained in a strained configuration. The ends 407, 408of the skin treatment device and/or ends 417, 418 of the ratchetelements 405, 406 may be used to grip and strain stress and/or stretchthe device 400. The first ratchet element 405 comprises pawls 415 thatengage sloped teeth 416 of the second ratchet element 406 and preventmovement backwards, loss of strain and/or complete relaxation of atensile stressed skin treatment device 400. As the ends 417, 418 of theratchet 404 move apart, the skin treatment device 400 is strained.Strain indicators or indicia 410 are on the second ratchet element 406adjacent the teeth 416 and indicate a degree of strain of the device 400based on which one of the teeth 416 engages the pawl 415. In the firstposition in FIG. 4A, the device 400 is relatively unstrained and in theposition indicated by strain indicator “0” 410-0. In FIG. 4B, the deviceis strained to a maximum amount as indicated by the strain indicator“C”41 c. Positions 0, A, B, and C 410-0, 410 a, 410 b and 410 ccorrespond to different teeth or positions on the ratchet 404 andaccordingly, different strain amounts or zero strain. A user may selectthe amount of strain. A user may use the indicators 410 to strain thedevice 400 to a selected or desired amount. A skin adhesive may beprovided on the skin attachment side of the device 400 to adhere thedevice 400 to the skin. The ends 417, 418 may be attached to the topsurface 419 of the device 400 by way of an adhesive, such as apreferentially removable adhesive as compared to skin adhesive used onskin interfacing surface. The ratchet elements 405, 406 may be peelablefrom the device or otherwise removably coupled to the device 400. Afterthe device is applied to a subject, the ratchet elements 405, 406 may beremoved leaving the device 400 on the skin. In other variations, one ormore of the ratchet elements and/or pawl elements may be left in placeor otherwise configured to be non-removable. In some variationscomprising removable elements used only during the application of thedevice, the removable elements may be attached to the device usingadhesives comprising a higher shear force resistance but a lower T-peelforce resistance, relative to the same force.

FIGS. 5A and 5B illustrate a strainable skin treatment device 500 whichmay be strained, stretched and/or tensile stressed by exerting atensioning force on ratcheted tabs 515, 516 or other manipulationelements of a straining structure 514. The skin treatment device 500 iscoupled at its first end 507 to a first attachment element 527. Thefirst attachment element 527 is coupled at its sides 531,532 to sidesupports 517, 518 of the straining structure 514. The second andopposite end 508 of the skin treatment device 500 is coupled to a secondattachment element 528. The sides 533,534 of second attachment elementare slidably positioned in slots 547, 548 formed in side supports 517,518 along a portion of the length. Ratcheted openings 557, 558 areformed through the top surface 550 of side supports 517, 518 along theportion of the length of the slots 547, 548. The tabs 515, 516 arecoupled through openings 557, 558 to sides 533, 534 respectively ofattachment element 528 within the slots 547, 548 respectively Theratchet 504 comprises the teeth 526 of the ratcheted openings 547, 548and pawls 525 formed in sides of the tabs 515, 516. Pawls 525 may bedisengaged from the teeth 516 by depressing the buttons 535, 536 on thetabs 515, 516 when straining the device 500. The pawls 525 engage theteeth 526 when the buttons 535, 536 are released to maintain the device500 in a strained configuration by pushing buttons 535, 536 to releasepawls 525. The buttons 535, 536 may be biased by a spring in a pawlengaging direction. When buttons 535, 536 are released at a selectedposition, a desired device strain is maintained or locked in.

The tabs 515, 516 may be extended to strain the attached dressing.Strain indicators or indicia 540, for example as described herein may beprovided on the straining structure 514 or device 500 to indicate adegree of strain of the device 500. The device may be strained aselectable amount based on which ones of the teeth 516 engage the pawls515. A user may use the indicators 540 to strain the device 500 to aselected or desired amount. A skin adhesive may be provided on the skinattachment side of the device 500 to adhere the device 500 to a subject.The attachment elements 527 and 528 may be attached to the treatmentdevice 500 by a preferentially removable adhesive as compared to skinadhesive used on skin interfacing surface of the device 500. The tabs515, 516 are coupled to the attachment element 528. The strainingstructure may be removable from the device 500 leaving the device 500 onthe skin.

FIGS. 6A and 6B illustrate a strainable skin treatment device 600 withhandles 615, 616 coupled to a first surface 601 of a treatment device600, for example, with a peelable adhesive. The skin treatment device600 may be strained and/or tensile stressed by exerting a tensioningforce on handles 615, 616. A strain limiter 610 is coupled to inneredges or walls 625, 626 of the handles 615, 616, respectively, forexample by adhering, welding, or overmolding. The strain limiter 610comprises at least one element that is bent, folded, arced or otherwiseshaped in a first configuration, for example, as shown for example, inFIG. 6A where the distance between the inner walls 625,626 is less thanwhen the device 600 is strained. When a user manually strains the deviceby separating the handles 615, 616, the strain limiter, straightens andmaintains the strain by engaging the side walls 625, 626 in a straightconfiguration. The strain limiter 610 may be constructed for example, ofLDPE, FEP, nylon, metal. The strain limiter 610 may be coupled to theside walls of the handles 615, 616. The strain limiter 610 and handles615, 616 may be released from the device 600 after it is applied to askin surface by peeling it away.

FIGS. 7A to 7D illustrate a strainable skin treatment device 700. Thetreatment device 700 is coupled to a sheet 710 at a first side 705 ofthe device, for example by way of an adhesive or other securing element720 capable of resisting shear stresses during straining, e.g., KAPTON®polyimide tape (DuPont, Wilmington, Del.). The device 700 may beanchored at a second end 708 to a support structure or backing 730 on afirst surface 733 of the backing 730, for example by way of a securingelement 740 such as a KAPTON®tape or adhesive that is removable from thedevice 700. The device 700 may be manually or otherwise strained bygrasping or pulling the sheet 710 in a straining direction. A secondopposing surface 735 of the backing 730 comprises a first row 736 ofsnap buttons 738 and a second (or more) row 737 of snap buttons 738 thatengage with a row 717 of mating snap buttons 727 on the sheet 710. Afterthe device 700 is strained by tensioning or pulling the sheet 710. Thesheet 710 may be folded back so that the row 717 is aligned with a rowof snap buttons on the backing 730. Each row may be positioned so that aknown amount of strain is created in the dressing depending on which rowis used. For example, the first row 736 of buttons 738 would becommensurate with an amount of strain that is less that the amount ofstrain commensurate with the second row 737 of buttons 738. Accordinglya user may select an amount of strain.

FIGS. 8A and 8B illustrate a strainable skin treatment device 800. Theskin treatment device 800 is coupled on a first side 804 to acorresponding first side 814 of a stiffer or more rigid backing 810. Acoupling element 806 is coupled to the second side 805 of the treatmentdevice 800. The coupling element 806 engages or snaps into a receivingelement 816 on the second side 815 of the backing 810. A user maymanipulate the coupling element 806 to strain the treatment device 800and then attach the coupling element 806 to the receiving element 816.The coupling element 806 and engaging element 816 may be snappedtogether and apart for example as with press fit a tongue in groove typeconnector arrangement. They also may be slid apart in a planar directionwith respect to the treatment device 800 and the backing 810. The skintreatment device 800 and the backing 810 may be removably coupled on thefirst sides 804, 814 by way of a peelable adhesive or other couplingmechanism. For example, the first sides 804, 814 may be coupled in asimilar manner as coupling element 806 and receiving element 816. Thus,after straining and attaching the treatment device 800 to the backing810 in a strained configuration, and after applying an adhesive side 802of the strained device 800 to skin to be treated, the backing 810 may bereleased from the device 800 by snapping or sliding the backing 810apart from the device 800.

FIGS. 9A and 9B illustrate a strainable skin treatment device 900. Afirst side 904 of a treatment device 900 is anchored at a first end 914of a more stiff or rigid backing 910 for example by a removable adhesiveor other removable coupling element. A hook or other coupling element906 is coupled to the second side 905 of the treatment device 900. Thecoupling element 906 engages or hooks onto the second side 915 of thebacking 910. A user may manipulate the coupling element 906 to strainthe treatment device 900 and then attach the coupling element 906 to thesecond side 915 of the backing 910. The skin treatment device 900 may beremovably coupled to the coupling element 906 by way of a peelableadhesive or other coupling mechanism. Thus, after straining andattaching the treatment device 900 to the backing 910 in a strainedconfiguration, and after applying an adhesive side 902 of the straineddevice 900 to skin to be treated, the backing 910 and coupling mechanismor hook 906 may be released from the device 900 by peeling apart fromthe device 900.

FIGS. 10A to 10C illustrate a strainable skin treatment device 1000. Theskin treatment device 1000 is coupled, for example with a peelableadhesive or other coupling mechanism, on opposing sides 1004, 1005adjacent opposing sides 1014, 1015 of a straining backing 1010 orapplicator 1010. The backing 1010 is shown in a folded configuration inFIG. 10A where a portion of the backing 1010 includes a tri-fold 1030.The fold 1030 decreases the length of the backing 1010 (FIG. 10A).Margins or areas 1024, 1025 of the opposing sides 1014, 1015 extendbeyond the sides 1004, 1005 of the device 1000 permitting a user tograsp or manipulate the free areas to exert and tensile or strainingforce on the device 1000 through the backing 1010. When a strainingforce is exerted, the tri-fold 1030 unfolds (FIG. 10B) and straightens(10C). The backing 1010 thus limits the strain of the device 1000. Afterthe device 1000 is strained, an adhesive side 1002 of the straineddevice 1000 may be applied to skin to be treated and the backing 1010may be removed from the device 1000 leaving the device 1000 on the skin.

As shown in FIGS. 10D to 10G, a plurality of folds 1070 may be providedin a backing 1050. Each fold 1070 may correspond or provide a particularstrain value or amount. A user may select numbers of folds depending ondesired strain. Folds 1070 may be configured to release sequentially asshown in FIGS. 10E to 10G, or may be secured and releasable, forstraining the dressing 1060, for example by a tape that resistsunfolding of a particular fold unless removed.

FIGS. 11A to 11D illustrate a strainable skin treatment device 1100. Theskin treatment device 1100 is coupled on opposing sides 1104, 1105 tosides of segments 1114, 1115 of a straining backing or applicator 1110.The device 1100 is free from to the backing 1110 in a straining zonebetween the opposing sides 1104, 1105. The backing 1110 comprisessegments 1114, 1115 having middle tab portions 1124, 1125 that overlapin the unstrained configuration (FIGS. 11A and 11B) wherein the backing1110 has a first length. Margins or areas 1134, 1135 of sides ofsegments 1114, 1115 extend beyond the sides 1104, 1105 of the device1100 permitting a user to grasp the free areas to exert a tensile orstraining force on the device 1100. When a straining force is exerted,the tabs 1124, 1125 of segments 1114, 1115 separate. After separation,when released, the edges 1144, 1145 of the tabs 1124, 1125 engage byoverlapping opposing edge portions 1155, 1154 of segments 1115, 1114respectively, maintaining the backing in a lengthened configuration andthus maintaining the strain in the device 1100. (FIGS. 11C and 11D).After the device 1100 is strained, an adhesive side 1102 of the straineddevice 1100 may be applied to skin to be treated and the backing 1110may be removed from the device 1100 leaving the device 1100 on the skin.

FIGS. 12A to 12D illustrate a strainable skin treatment device 1200. Theskin treatment device 1200 is coupled on opposing sides 1204, 1205 tosides of segments 1214, 1215 of a straining backing or applicator 1210.The device 1200 is free from to the backing 1210 in a straining zonebetween the opposing sides 1204, 1205. The backing 1210 comprisessegments 1214, 1215 having middle edges 1224, 1225 that overlap in theunstrained configuration (FIGS. 12A and 12B) wherein the backing 1210has a first length. Handle elements 1234, 1235 of sides of segments1214, 1215 permit a user to grasp and manipulate the segments 1214, 1215to exert a tensile or straining force on the device 1200. When astraining force is exerted, the edges 1224, 1225 of segments 1214, 1215separate. After separation, when released, the edges 1224, 1225 of eachhave features that engage with each other, maintaining the backing 1210in a lengthened configuration and thus maintaining the strain in thedevice 1200. (FIGS. 12C and 12D). The features may be, for example amortise and tenon (1244) type of joint. A guide 1265 on the segment 1215may also guide the edges 1224, 1225 in to an aligned engagement when thedevice 1200 is strained. After the device 1200 is strained, the adhesiveside 1202 of the strained device 1200 may be applied to skin to betreated and the backing 1210 may be removed from the device 1200 leavingthe device 1200 on the skin.

FIGS. 13A to 13C illustrate a strainable skin treatment device 1300. Afirst side 1304 of a treatment device 1300 is anchored at a first side1314 of a more stiff or rigid backing 1310 for example by a removableadhesive or other removable coupling element. The treatment device 1300includes slits or breaks 1303 that form fingers 1307. The backing 1310includes movable fingers 1317 that are extendable away from first end1314 of backing 1310. The fingers 1307 of the device 1300 are eachattached to a corresponding movable finger 1317 of the backing 1310 at asecond side 1315 of the backing 1310. Each of the movable fingers 1317may be extended away from side 1314 to strain a corresponding finger1307 of the device. A user may select one or more or all fingers 1307 tobe strained. Each finger 1307 may also be variably strained to a desireddegree. FIG. 13A illustrates an unstrained device 1310 on the backing.FIG. 13B illustrates an individual finger 1307 strained. FIG. 13Cillustrates all fingers 1307 strained. The skin treatment device 1300may be removably coupled to the side 1314 of the backing 1310 and/oredges 1305 of the finger 1307 by way of a peelable adhesive or othercoupling mechanism. Thus, after straining and after applying theadhesive side 1302 of the strained device 1300 to skin to be treated,the backing 1310 including the fingers 1317 may be released from thedevice 1300 for example by peeling apart from the device 1300.

FIGS. 14A and 14B illustrate a strainable skin treatment device 1400.The skin treatment device 1400 is coupled on a first side 1404 to acorresponding first side 1414 of a stiffer or more rigid backing 1410. Astraining element 1450 is coupled to the second side 1405 of thetreatment device 1400. The straining element 1450 comprises a first baror handle 1451 that is coupled to the second side 1405 of the treatmentdevice 1400, for example, by way of an adhesive or other couplingelement. The straining element 1450 further comprises connecting bars1452 that extend through slots 1415 in rigid backing 1410 and connectthe first bar or handle 1451 to a second bar or handle 1453. A user mayuse the straining element 1450 to strain the treatment device 1400 bygrasping the second handle or bar 1453 and sliding the connecting bars1452 through the slots 1415 (FIG. 14B). The skin treatment device 1400and the backing 1410 may be removably coupled on the first sides 1404,1414 by way of a peelable adhesive or other coupling mechanism. Thus,after straining and after applying the adhesive side 1402 of thestrained device 1400 to skin to be treated, the backing 1410 may bereleased from the device 1400 by peeling the backing 1410 from thedevice 1400.

FIGS. 14C and 14D illustrate the strainable skin treatment device 1400and rigid backing 1410 of FIGS. 14A and 14B. A user may use thestraining element 1450 to strain the treatment device 1400 by graspingthe handle or bar 1453 and rotating it so that the connecting bars 1452rotate with in the slot 1415 as shown in FIG. 14D. After straining andafter applying the adhesive side 1402 of the strained device 1400 toskin to be treated, the backing 1410 may be released from the device1400 by peeling the backing 1410 from the device 1400.

FIGS. 15A to 15B illustrate a method and device for straining a skintreatment device 1500. A strainable skin treatment device 1500 iscoupled over a window 1520 of a frame 1510 interfacing side 1515 of theframe 1510. The device 1500 may include extension sheets 1506 coupled atsides 1504, 1505 of the device 1500. The extension sheets 1506 may beflexible and relatively less elastic or inelastic than device 1500. Astraining device 1530 comprises a protruding element 1535 on a handle1538 where the protruding element 1535 is shaped to fit within thewindow 1520 of the frame 1510. In use, the protruding element 1535 isplaced between adjacent the treatment device 1500 and is used to pushthe treatment device 1500 through the window 1520, thereby straining thetreatment device 1500. The handle 1538 and frame 1510 may be usedtogether to apply the strained device 1500 to skin to be treated.

FIG. 16A illustrates a strainable dressing 1600 with an applicator ortensioning device 1610 that is described in detail in U.S. patentapplication Ser. No. 13/345,524 incorporated in its entirety herein byreference. The dressing 1600 may be strained to different distances toaccommodate for multiple forces and tensile strengths within thedressing. Different forces may be desired at different locations, areasor parts of the dressing. The dressing 1600 is illustrated in anunstrained configuration in FIG. 16A. A flexible, relatively inelasticanchor sheet 1624 couples a first side 1604 of the device 1600 of a freeside 1614 of a base support 1611 of the applicator 1610. A strainingsheet 1625 couples a second side 1605 of the device 1600 to the movablecover 1612 which is pivotably or hingedly coupled the side 1615 of thebase support 1611. When the cover 1612 is pivoted and opened, it acts tostrain the device 1600. A skin adhesive is applied to the skin adhesiveside 1602 of the device 1600. A strain limiting structure 1640 iscoupled to the device 1600, e.g., the opposing back surface 1603 of thedevice 1600. The strain limiter 1640 comprises a plurality of strainlimiting elements 1641, 1642, 1643. Each strain limiting element mayprovide a different degree of strain limitation. According to avariation, a first central strain limiter 1642 may permit apredetermined amount of strain at a central location. Adjacent strainlimiters 1641, 1643 may permit a predetermined amount of strain that mayor may not be different and may or may not be more or less than theamount of central strain. According to a variation, the adjacent strainlimiters 1641, 1643 permit a lesser amount of strain than the centralstrain limiter 1642. Varied strain at different locations may beselected or provided on different dressings to provide a variety ofdressings that may be targeted to particular body locations orapplications of use.

According to a variation, in order to reduce irritation around the edgesor to focus compressive forces near a wound or treatment site, thedressing may be strained to a greater degree, or force towards themiddle of the dressing. Also forces and tensile strengths may becontrolled towards the edges of the dressings within the dressing.

The strain limiters may be constructed of a flexible less elastic, ascompared to the dressing material, such as an LDPE that limits strainbetween opposing locations where the strain limiter is coupled to thedressing. The strain limiting elements 1641, 1642, 1643 may be attachedto the back surface of the dressing with a tape 1648 such as KAPTON®tape, or peelable adhesive. An acrylic adhesive may be used to attachthe LDPE to the back side of the kapton. After the dressing is strainedand applied to a subject, the strain limiter may or may not be released.

While this invention has been particularly shown and described withreferences to embodiments thereof, it will be understood by thoseskilled in the art that various changes in form and details may be madetherein without departing from the scope of the invention. For all ofthe embodiments described above, the steps of the methods need not beperformed sequentially.

1. A skin treatment system, comprising a controlled strain treatmentdevice.